Topic: Diabetes Research Network, Oral and Gastrointestinal
Conditions
Interventions
Participants will be randomly assigned to either usual periodontal care (supragingival scaling and polishing) or to an intensive periodontal treatment (test group). Blood samples will be collected at
Sponsors
UCL Eastman Dental Institute and Hospital, University College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject aged over 18 years, either sex 2. Subject diagnosed with type 2 diabetes mellitus 3. Subject consenting to the study 4. Subject with signs of active moderate to severe periodontitis (at least 20 periodontal pockets, probing pocket depth [PPD] greater than 4 mm and bleeding on probing) 5. Minimum of 15 teeth present
Exclusion criteria
Exclusion criteria: 1. Pregnancy/lactation 2. Subjects on chronic treatment with phenytoin or cyclosporin 3. Subjects with known human immunodeficiency virus (HIV) or hepatitis (B, C) or uncontrolled systemic diseases (cardiovascular diseases including hypertension, liver, pulmonary diseases, end stage renal failure) and/or neoplasm 4. Subjects who require antibiotic coverage for periodontal procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c between test and control group after 12 months of completion of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 26/09/2017: 1. HbA1c difference at 6 months 2. Glucose, insulin, creatinine and flow-mediated dilatation at 6 and 12 months 3. Adverse events at any study visits 4. Periodontal clinical parameters, lipid fractions, inflammatory and endothelial cell surface markers at 2, 6 and 12 months 5. eGFR and patient reported outcomes at 12 months 6. Changes in dental plaque composition at 2, 6 and 12 months visits 7. Laser Doppler flowmetry of the skin at all study visits, a subgroup of 30 patients will also have laser Doppler measures of their gums following intensive gum therapy 8. Intima-media thickness and endothelium pulse amplitude tonometry changes at 12 months (subgroup of 115 patients) Previous secondary outcome measures: 1. To assess the impact of extensive periodontal therapy on: 1.1. Markers of gingival wound healing 1.2. Assessment of endothelial function 1.3. Subclinical atherosclerosis 1.4. Systemic inflammation 1.5. Proteinuria 1.6. Microbiological differences In individuals with type 2 diabetes compared to control 2. To assess changes in quality of life, both related to diabetes and oral health, after extensive periodontal therapy compared to control | — |
Countries
United Kingdom
Outcome results
None listed